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FDA 510(k) Application Details - K053146
Device Classification Name
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510(K) Number
K053146
Device Name
QUICKVUE INFLUENZA A + B TEST
Applicant
QUIDEL CORP.
10165 MCKELLAR CT.
SAN DIEGO, CA 92121 US
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Contact
JOHN D TAMERIUS
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Regulation Number
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Classification Product Code
PSZ
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Date Received
11/10/2005
Decision Date
12/14/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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